Operations Compliance Specialist

at  Thermo Fisher Scientific

KNOWLEDGE, SKILLS, ABILITIES

• Strong understanding of production processes and the biopharma production environment.
• Excellent knowledge of cGMP and other regulatory requirements related to cleanroom operations.
• Familiarity with cGMP quality systems, including change control, deviations, investigations, risk assessments, and ensuring good documentation practices.
• Proactively takes initiative and consistently achieves desired outcomes.
• Exceptional problem-solving skills.
• Highly organized, efficient, and focused on achieving results.
• Proficient in Microsoft Office tools, including report writing and graphing.
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• Conduct daily compliance walkthroughs, meticulously checking items such as fit and finish, up-to-date logbooks, correct execution of aseptic practices, acceptable cleaning standards, accurate material labeling, and no expired items.
• Collaborate with area leadership to identify and close any compliance gaps.
• Take immediate action to remediate any compliance gaps that are discovered.
• Provide training and support to employees ensuring adherence to established procedures and guidelines.
• Place work orders as necessary to address compliance issues.
• Contribute to the identification of process improvement opportunities and support the implementation of corrective actions regarding compliance